Chronic DiseasePhase 2NCT02784262
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis
A Phase 2 study testing botox injection Multiguide in people with Chronic Disease and Nasal Polyposis, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic rhinosinusitis in several ways. Patients have significantly more severe symptom burden and worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Disease, Nasal Polyposis, Rhinitis
- What is being tested?
- botox injection Multiguide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2016to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- chronic rhinosinusitis with nose polyps (CRSwNP) according to European position paper on rhinosinusitis and nasal polyps (EPOS) criteria
- no satisfactory effect of medicinal or surgical treatment
Who cannot join
- systemic or local disease or condition that may result in a higher risk for complications
- psychiatric disorder that is indicates against the treatment
- pregnancy, breastfeeding, fertile female not using contraception
- abuse of drugs, narcotics or alcohol
- hypersensitivity against marcain, lidocain, xylocain, or adrenalin, and similar drugs
- anatomical conditions that hinder injection
Show all 10Show fewer
- known sensitivity for botulinum toxin type A or for adjuvant substances
- treatment with drugs that interact with botulinum toxin type A:
- suspicion of polyps caused by an allergy
- suspicion of Samters triade
Trial locations and contacts
1 site in 1 country.
About this study
Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic rhinosinusitis in several ways. Patients have significantly more severe symptom burden and worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many patients return to the health care providers with persistent symptoms after repeated medical and surgical treatment. Patients have usually tried several different types of treatments, ranging from less invasive procedures to extensive surgical treatment. The surgical treatment is often repeated several times. The most common surgical treatment is functional endoscopic sinus surgery, another established procedure is Vidian neurectomy.
The main object of this pilot study is to investigate the safety of onabotulinumtoxin A towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data will also be collected to provide indication on whether future placebo-controlled studies should be performed.
Read more
Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling, secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9 months and will not lead to damage of the nerve.
This study opens up for improved treatment with less complications.
- Conditions
- Chronic Disease, Nasal Polyposis, Rhinitis
- Being tested
- botox injection Multiguide
- Keywords
- Botulinum Toxin Type A, Block, Sphenopalatine Ganglion
- Medical subject headings
- Chronic Disease, Nasal Polyps, Rhinitis, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botox injection MultiguideDrug
Also called Botulinum toxin type A
botox injection under CT/MR navigation and with the navigation tool MultiGuide
| Study group | Role | What they receive |
|---|---|---|
| botox injection | Experimental | * Preoperative medication: Paracetamol 1,5g oral, diclofenac 50mg (evt ibuprofen 600mg) oral and/or diazepam 5-10 mg oral.
* Skin and tissue inside the projected injection canal will be infiltrated with 5-10ml Marcain-Adrenalin (5mg/ml + 5microg/ml) for local anaesthesia.
* Localization will be confirmed with help of navigation before the medication will be given. Intravascular injection will be prevented by control of aspiration. Receives: Drug: botox injection Multiguide |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Registration of all adverse events sorted by probable relation to botox or surgery. Data collected from symptom diary, in addition to an open question at consultation and put into the Case Report Form (CRF) by physician or nurse.
Measured: from day 1 to 7 post surgery
Secondary outcomes (8)
change in symptom index on a visual analog scale nasal obstruction/running nose
Measured: 3 months
change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22)
Measured: 3 months
change in nose-sinus related quality of life assessed with a visual analog scale (VAS)
Measured: 3 months
change in the geometrics of the nose assessed by acoustic rhinometry
Measured: 3 months
change in air flow in the nose measured by peak nasal inspiratory flow (PNIF)
Measured: 3 months
change in polyp mass assessed by magnetic resonance imaging (MRI)
Measured: 3 months
change in polyp mass assessed by computer tomography (CT)
Measured: 3 months
change in quality of life expressed by Patients' Global Impression of Change (PGIC)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startOct 2016
- Primary completion4 Sep 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Lars Jacob Stovner, md prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784262
- Sponsor's protocol ID
- 011015-01
- Other IDs
- 2015-004377-33, 2015
- Status last verified
- Oct 2021
- First submitted
- 24 May 2016
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Jamtoy KA, Tronvik E, Bratbak DF, Crespi J, Stovner LJ, Aschehoug I, Thorstensen WM. OnabotulinumtoxinA injection towards the SPG for treating symptoms of refractory chronic rhinosinusitis with nasal polyposis: a pilot study. Acta Otolaryngol. 2021 Oct;141(10):934-940. doi: 10.1080/00016489.2021.1982146. Epub 2021 Oct 11.
PubMed 34633904
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis
- ClinicalTrials.gov ID
- NCT02784262
- Acronym / sponsor ID
- 011015-01
- Conditions
- Chronic Disease, Nasal Polyposis, Rhinitis
- Keywords
- Botulinum Toxin Type A, Block, Sphenopalatine Ganglion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Oct 2016 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic rhinosinusitis in several ways. Patients have significantly more severe symptom burden and worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many patients return to the health care providers with persistent symptoms after repeated medical and surgical treatment. Patients have usually tried several different types of treatments, ranging from less invasive procedures to extensive surgical treatment. The surgical treatment is often repeated several times. The most common surgical treatment is functional endoscopic sinus surgery, another established procedure is Vidian neurectomy.
The main object of this pilot study is to investigate the safety of onabotulinumtoxin A towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data will also be collected to provide indication on whether future placebo-controlled studies should be performed.
Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling, secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9 months and will not lead to damage of the nerve.
This study opens up for improved treatment with less complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| botox injection | Experimental | Drug: botox injection Multiguide* Preoperative medication: Paracetamol 1,5g oral, diclofenac 50mg (evt ibuprofen 600mg) oral and/or diazepam 5-10 mg oral. * Skin and tissue inside the projected injection canal will be infiltrated with 5-10ml Marcain-Adrenalin (5mg/ml + 5microg/ml) for local anaesthesia. * Localization will be confirmed with help of navigation before the medication will be given. Intravascular injection will be prevented by control of aspiration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent
- chronic rhinosinusitis with nose polyps (CRSwNP) according to European position paper on rhinosinusitis and nasal polyps (EPOS) criteria
- no satisfactory effect of medicinal or surgical treatment
Key exclusion criteria (10 listed)
- systemic or local disease or condition that may result in a higher risk for complications
- psychiatric disorder that is indicates against the treatment
- pregnancy, breastfeeding, fertile female not using contraception
- abuse of drugs, narcotics or alcohol
- hypersensitivity against marcain, lidocain, xylocain, or adrenalin, and similar drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botox injection MultiguideAlso: Botulinum toxin type Abotox injection under CT/MR navigation and with the navigation tool MultiGuide | Drug | botox injection |
Primary outcome
adverse events
Time frame: from day 1 to 7 post surgery
Registration of all adverse events sorted by probable relation to botox or surgery. Data collected from symptom diary, in addition to an open question at consultation and put into the Case Report Form (CRF) by physician or nurse.
8 secondary outcomes
change in symptom index on a visual analog scale nasal obstruction/running nose
Time frame: 3 months
change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22)
Time frame: 3 months
change in nose-sinus related quality of life assessed with a visual analog scale (VAS)
Time frame: 3 months
change in the geometrics of the nose assessed by acoustic rhinometry
Time frame: 3 months
change in air flow in the nose measured by peak nasal inspiratory flow (PNIF)
Time frame: 3 months
change in polyp mass assessed by magnetic resonance imaging (MRI)
Time frame: 3 months
change in polyp mass assessed by computer tomography (CT)
Time frame: 3 months
change in quality of life expressed by Patients' Global Impression of Change (PGIC)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Results publication: PubMed 34633904Jamtoy KA, Tronvik E, Bratbak DF, Crespi J, Stovner LJ, Aschehoug I, Thorstensen WM. OnabotulinumtoxinA injection towards the SPG for treating symptoms of refractory chronic rhinosinusitis with nasal polyposis: a pilot study. Acta Otolaryngol. 2021 Oct;141(10):934-940. doi: 10.1080/00016489.2021.1982146. Epub 2021 Oct 11.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Jacob Stovner, md prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing botox injection Multiguide in people with Chronic Disease and Nasal Polyposis, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events (time frame: from day 1 to 7 post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.